| Microny (P970013/S088) | ABBOTT MEDICAL | 2021-07-07 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S393) | ABBOTT MEDICAL | 2021-07-07 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S069) | ABBOTT MEDICAL | 2021-07-07 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MR Conditional) (P030035/S187) | ABBOTT MEDICAL | 2021-07-07 |
| IsoFlex Optim (P960030/S075) | ABBOTT MEDICAL | 2021-07-07 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960013/S119) | ABBOTT MEDICAL | 2021-07-07 |
| Harmony TPV System (P200046/S004) | Medtronic, Inc. | 2021-07-07 |
| Optune System (P100034/S026) | Novocure, GmbH | 2021-07-07 |
| therascreen EGFR RGQ PCR Kit (P120022/S022) | QIAGEN GmbH | 2021-07-07 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| ROTAPRO Rotational Atherectomy System (P900056/S193) | Boston Scientific Corp | 2021-07-06 |
| Orthovisc (P030019/S026) | Anika Therapeutics, Inc. | 2021-07-02 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Pri (P980016/S786) | Medtronic Cardiac Rhythm Disease Management | 2021-07-02 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D (P010031/S749) | Medtronic Cardiac Rhythm Disease Management | 2021-07-02 |
| Spinal Cord Stimulation (SCS) System (P010032/S173) | ABBOTT MEDICAL | 2021-07-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-E (P150003/S077) | Boston Scientific Corporation | 2021-07-02 |
| BRACAnalysis CDx (P140020/S021) | Myriad Genetic Laboratories | 2021-07-02 |
| Dorsal Root Ganglion (DRG) Stimulation System (P150004/S045) | ABBOTT MEDICAL | 2021-07-02 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P110010/S196) | Boston Scientific Corp | 2021-07-02 |
| AcrySof Intraocular Lenses (P930014/S131) | Alcon Laboratories, Inc. | 2021-07-01 |
| Micra AV TPS and Micra TPS (P150033/S112) | Medtronic, Inc. | 2021-07-01 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus- (P150003/S076) | Boston Scientific Corporation | 2021-07-01 |
| CardioMEMS HF System (P100045/S055) | ABBOTT MEDICAL | 2021-07-01 |
| AcrySof IQ ReSTOR Intraocular Lenses (P040020/S093) | Alcon Research, Ltd. | 2021-07-01 |
| EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System (P130021/S098) | Medtronic, Inc. | 2021-06-30 |
| FoundationOne CDx (F1CDx) (P170019/S023) | Foundation Medicine, Inc. | 2021-06-30 |
| LCS Total Knee System (P830055/S269) | Depuy, Inc. | 2021-06-30 |
| Transcend Hip Articulation System (P010001/S023) | Ceramtec GmbH | 2021-06-30 |
| ProstaLund CoreTherm System Microwave Thermotherapy for BPH (P010055/S011) | Prostalund AB | 2021-06-30 |
| R3 Delta Ceramic Hip System (P150030/S009) | Smith & Nephew, Inc. | 2021-06-30 |
| Medtronic Deep Brain Stimulation Therapy System (P960009/S400) | Medtronic, Inc. | 2021-06-30 |
| R3 Delta Ceramic Acetabular System (P150030/S010) | Smith & Nephew, Inc. | 2021-06-30 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S081) | Hologic, Inc. | 2021-06-30 |
| Restore, Itrel, Synergy, Intellis , Vanta and Sequentia LT Spinal Cord Stimulation Systems and Pisces, Specify, and Vect (P840001/S493) | Medtronic Neuromodulation | 2021-06-30 |
| Synvisc and Synvisc-One (P940015/S048) | Sanofi Genzyme Corp. | 2021-06-29 |
| Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT (P010031/S742) | Medtronic Cardiac Rhythm Disease Management | 2021-06-29 |
| TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S (P980040/S138) | Johnson & Johnson Surgical Vision, Inc. | 2021-06-29 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S021) | Bimini Health Tech | 2021-06-29 |
| Edwards Commander Delivery System, Crimper (P200015/S010) | Edwards Lifesciences, LLC | 2021-06-29 |
| Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob (P980016/S780) | Medtronic Cardiac Rhythm Disease Management | 2021-06-29 |
| VICI VENOUS STENT System (P180013/S007) | Boston Scientific Corporation | 2021-06-29 |
| R3 Delta Ceramic Acetabular System (P150030/S011) | Smith & Nephew, Inc. | 2021-06-29 |
| TECNIS Simplicity Delivery System (P980040/S137) | Johnson & Johnson Surgical Vision, Inc. | 2021-06-29 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S319) | ABBOTT MEDICAL | 2021-06-28 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S067) | ABBOTT MEDICAL | 2021-06-28 |
| Microny family of Pacemakers (P970013/S087) | ABBOTT MEDICAL | 2021-06-28 |
| Impella RP System (P170011/S032) | Abiomed, Inc. | 2021-06-28 |
| Zoll AED 3 and Zoll AED 3 Automatic (P160015/S005) | ZOLL Medical Corporation | 2021-06-28 |
| HeartWare Ventricular Assist System (P100047/S178) | Medtronic | 2021-06-28 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S080) | Abiomed, Inc. | 2021-06-28 |
| ZOLL AED 3 BLS Device (P160022/S019) | ZOLL Medical Corporation | 2021-06-28 |
| Impella RP System (P170011/S026) | Abiomed, Inc. | 2021-06-28 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S186) | ABBOTT MEDICAL | 2021-06-28 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S437) | ABBOTT MEDICAL | 2021-06-28 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S392) | ABBOTT MEDICAL | 2021-06-28 |
| Impella RP with SmartAssist System (P170011/S030) | Abiomed, Inc. | 2021-06-28 |
| Restylane® Contour (P140029/S032) | Q-Med AB | 2021-06-28 |
| Implantable System for Remodulin (P140032/S072) | Medtronic, Inc. | 2021-06-25 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S490) | Medtronic Neuromodulation | 2021-06-25 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S334) | Medtronic Neuromodulation | 2021-06-25 |
| NATRELLE Silicone-Filled Breast Implants (P990074/S046) | Allergan | 2021-06-25 |
| Orchestra, Orchestra Plus, and Smart Touch programmers (P980049/S142) | MicroPort CRM USA, Inc. | 2021-06-25 |
| NATRELLE Saline-Filled Breast Implants (P020056/S055) | Allergan | 2021-06-25 |
| Micra VR TPS (P150033/S111) | Medtronic, Inc. | 2021-06-25 |
| XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary (P110019/S115) | Abbott Vascular | 2021-06-25 |
| LifePulse High Frequency Ventilator (P850064/S046) | Bunnell, Inc. | 2021-06-25 |
| RADIESSE (+) Lidocaine Dermal Filler (P050052/S131) | Merz North America, Inc. | 2021-06-25 |
| Alizea and Celea Pacemakers (P950029/S130) | MicroPort CRM USA, Inc. | 2021-06-25 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S375) | Medtronic, Inc. | 2021-06-25 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S116) | Vistakon, Division of Johnson & Johnson Vision Car | 2021-06-25 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S229) | Medtronic Neuromodulation | 2021-06-25 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S401) | Medtronic, Inc. | 2021-06-25 |
| SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9 (P000025/S120) | Med-El Corp. | 2021-06-25 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S074) | St Jude Medical | 2021-06-25 |
| FlexAbility Ablation Catheter (FlexAbility) and FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S077) | ABBOTT MEDICAL | 2021-06-25 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S067) | Inspire Medical Systems | 2021-06-24 |
| myChoice HRD CDx (P190014/S005) | Myriad Genetic Laboratories, Inc. | 2021-06-24 |
| Prismaflex TPE2000 Set (P830063/S019) | Vantive US Healthcare, LLC | 2021-06-24 |
| Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus, Rotalink Burr), ROTAPRO Rotational Atherectomy Syst (P900056/S192) | Boston Scientific Corp | 2021-06-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S007) | Biotronik AG | 2021-06-24 |
| Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S255) | Medtronic, Inc. | 2021-06-23 |
| Attain StarFix Lead (P060039/S107) | Medtronic, Inc. | 2021-06-23 |
| Juvéderm Hyaluronate Gel Implants (P050047/S081) | Allergan | 2021-06-23 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S161) | Medtronic, Inc. | 2021-06-23 |
| HeartWare Ventricular Assist System (P100047/S182) | Medtronic | 2021-06-23 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S477) | Medtronic, Inc. | 2021-06-23 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S027) | Physio-Control, Inc. | 2021-06-23 |
| CapSureFix MRI Lead (P090013/S315) | Medtronic, Inc. | 2021-06-23 |
| Transvene CS/SVC Lead (P980050/S133) | Medtronic, Inc. | 2021-06-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead (P930039/S228) | Medtronic, Inc. | 2021-06-23 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S446) | Medtronic, Inc. | 2021-06-23 |
| Neuro Cochlear Implant System (P200021) | Oticon Medical | 2021-06-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead (P830061/S195) | Medtronic Cardiac Rhythm Disease Management | 2021-06-23 |
| Juvéderm Hyaluronate Gel Implants (P110033/S060) | Allergan | 2021-06-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S155) | Medtronic Cardiac Rhythm Disease Management | 2021-06-23 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S015) | Abbott Vascular | 2021-06-22 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S228) | Medtronic Neuromodulation | 2021-06-22 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S333) | Medtronic Neuromodulation | 2021-06-22 |
| AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL) (P930014/S136) | Alcon Laboratories, Inc. | 2021-06-22 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S026) | Physio-Control, Inc. | 2021-06-22 |